§1602 — Title 21 Food and Drugs | U.S. Code

Summary

Defines the main words used in the chapter about implants. Biomaterials supplier means a business that supplies parts or raw materials used to make implants, and it also covers those who filed master files with the Secretary for premarket device approval or who license others to make those parts or materials. Claimant means anyone who brings a lawsuit over harm linked to an implant, and it also includes a deceased person’s estate or a minor’s parent or guardian when they sue; it does not include a health-care provider when the implant is only incidental to their skilled care, a manufacturer/seller/biomaterials supplier, or someone claiming harm from silicone gel or its envelope (and that exclusion generally may not be shown to a jury or used in court except to show this law applies). Component part means a manufactured piece of an implant, even if it also has other uses or only becomes an implant when combined with other pieces. Harm means injury, illness, death, or related loss to a person, but not commercial loss or damage to the implant itself. Implant means a medical device meant to stay in the body 30 days or more, or to contact internal tissue or fluids through a surgical opening for less than 30 days, and it includes suture materials used in implant procedures. Manufacturer means a person who makes or processes an implant and must register with the Secretary under section 360 and list the device under section 360(j). Medical device has the meaning in section 321(h) and includes device parts of combination products under section 353(g). Raw material means a substance with general uses that can be used for things other than implants. Secretary means the Secretary of Health and Human Services. Seller means a business that sells, distributes, leases, packages, labels, or otherwise puts an implant into commerce, but not a seller of real property, not a health-care provider when the implant is incidental to skilled care, and not someone acting only in a financial role.

Title 21, §1602

Food and Drugs — Source: USLM XML via OLRC

As used in this chapter:

(1)(A)The term “biomaterials supplier” means an entity that directly or indirectly supplies a component part or raw material for use in the manufacture of an implant.

(B)Such term includes any person who—

(i)has submitted master files to the Secretary for purposes of premarket approval of a medical device; or

(ii)licenses a biomaterials supplier to produce component parts or raw materials.

(2)(A)The term “claimant” means any person who brings a civil action, or on whose behalf a civil action is brought, arising from harm allegedly caused directly or indirectly by an implant, including a person other than the individual into whose body, or in contact with whose blood or tissue, the implant is placed, who claims to have suffered harm as a result of the implant.

(B)With respect to an action brought on behalf of or through the estate of a deceased individual into whose body, or in contact with whose blood or tissue the implant was placed, such term includes the decedent that is the subject of the action.

(C)With respect to an action brought on behalf of or through a minor or incompetent, such term includes the parent or guardian of the minor or incompetent.

(D)Such term does not include—

(i)a provider of professional health care services in any case in which—

(I)the sale or use of an implant is incidental to such services; and

(II)the essence of the professional health care services provided is the furnishing of judgment, skill, or services;

(ii)a person acting in the capacity of a manufacturer, seller, or biomaterials supplier; or

(iii)a person alleging harm caused by either the silicone gel or the silicone envelope utilized in a breast implant containing silicone gel, except that—

(I)neither the exclusion provided by this clause nor any other provision of this chapter may be construed as a finding that silicone gel (or any other form of silicone) may or may not cause harm; and

(II)the existence of the exclusion under this clause may not—

(aa)be disclosed to a jury in any civil action or other proceeding; and

(bb)except as necessary to establish the applicability of this chapter, otherwise be presented in any civil action or other proceeding.

(3)(A)The term “component part” means a manufactured piece of an implant.

(B)Such term includes a manufactured piece of an implant that—

(i)has significant non-implant applications; and

(ii)alone, has no implant value or purpose, but when combined with other component parts and materials, constitutes an implant.

(4)(A)The term “harm” means—

(i)any injury to or damage suffered by an individual;

(ii)any illness, disease, or death of that individual resulting from that injury or damage; and

(iii)any loss to that individual or any other individual resulting from that injury or damage.

(B)The term does not include any commercial loss or loss of or damage to an implant.

(5)The term “implant” means—

(A)a medical device that is intended by the manufacturer of the device—

(i)to be placed into a surgically or naturally formed or existing cavity of the body for a period of at least 30 days; or

(ii)to remain in contact with bodily fluids or internal human tissue through a surgically produced opening for a period of less than 30 days; and

(B)suture materials used in implant procedures.

(6)The term “manufacturer” means any person who, with respect to an implant—

(A)is engaged in the manufacture, preparation, propagation, compounding, or processing (as defined in section 360(a)(1) of this title) of the implant; and

(B)is required—

(i)to register with the Secretary pursuant to section 360 of this title and the regulations issued under such section; and

(ii)to include the implant on a list of devices filed with the Secretary pursuant to section 360(j) of this title and the regulations issued under such section.

(7)The term “medical device” means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.

(8)The term “raw material” means a substance or product that—

(A)has a generic use; and

(B)may be used in an application other than an implant.

(9)The term “Secretary” means the Secretary of Health and Human Services.

(10)(A)The term “seller” means a person who, in the course of a business conducted for that purpose, sells, distributes, leases, packages, labels, or otherwise places an implant in the stream of commerce.

(B)The term does not include—

(i)a seller or lessor of real property;

(ii)a provider of professional health care services in any case in which—

(I)the sale or use of the implant is incidental to such services; and

(II)the essence of the professional health care services provided is the furnishing of judgment, skill, or services; or

(iii)any person who acts in only a financial capacity with respect to the sale of an implant.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.

§1602 Definitions

Summary

Title 21, §1602

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

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